Datascope recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories (Model 0684-00-0295-01) due to discrepant labeling on inner and outer packaging. Affected units may have safety risks.
There is discrepant labeling on the inner and outer packaging of the device.
Datascope is recalling a specific model of intra-aortic balloon catheter because the inner and outer packaging have different labels. This labeling issue could lead to confusion about the product's specifications, potentially affecting safe medical use.
The inner and outer packaging have different labels, which could lead to confusion about the product's specifications. This might result in incorrect use during medical procedures, potentially affecting patient safety.
Healthcare professionals who use this specific model of intra-aortic balloon catheter are likely affected. Patients receiving this device during procedures may be at risk if the labeling discrepancy causes incorrect usage.
Check for the model number 0684-00-0295-01 on the packaging. The device also has a unique identifier (UDI-DI: 10607567107974) and lot number 3000344298.
Verify that the inner and outer packaging match the model number 0684-00-0295-01 and lot number 3000344298.
The recall is due to labeling discrepancies, not safety issues. The product may still be safe if labels match, but affected units should be checked.
Look for the model number 0684-00-0295-01 on the packaging, along with the lot number 3000344298 and unique identifier 10607567107974.
The recall does not require immediate action. Check the packaging labels to confirm if the product matches the recalled model.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0311-2025 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0311-2025 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
